Urothelial CarcinomaPhase 1/2NCT03502785
INO-5401 + INO-9012 in Combination With Atezolizumab in Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
A Phase 1/2 study testing INO-5401, INO-9012 and Atezolizumab in people with Urothelial Carcinoma, run by Inovio Pharmaceuticals at 11 sites in United States.
Trial summary
This was a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- INO-5401, INO-9012 and Atezolizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 11 sitesUnited States
- Study dates
- 24 Jul 2018to 9 May 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign an Informed Consent Form (ICF);
- Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra);
- For Cohort A: Participants who have radiographically confirmed disease progression during or following treatment with an anti-PD-1/PD-L1 based therapy;
- For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UCa and ineligible ("unfit") for cisplatin-based chemotherapy;
- Have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
- Have a performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Performance Scale;
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- Have life expectancy of >/= 3 months;
- Be willing to provide a tissue sample for pre-treatment intra-tumoral assessment of proinflammatory and immunosuppressive factors;
- Have electrocardiogram (ECG) with no clinically significant findings as assessed by the investigator performed within 28 days prior to first dose;
- Demonstrate adequate hematological, renal, hepatic, and coagulation function;
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment;
- For male participants: agreement not to father a child. Participants must be surgically sterile (e.g, vasectomy) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment.
Who cannot join
- Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0 as well as current participation or recipient of treatment on a clinical trial within 28 days prior to Day 0;
- Documented active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Malignancies other than UCa within 3 years prior to Day 0, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome;
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies;
- Treatment with systemic immunostimulatory agents;
- Treatment with systemic immunosuppressive medication;
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- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
- Known hypersensitivity allergy or contraindication to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the PD-1/PD-L1 inhibitor formulation;
- Active or history of autoimmune disease or immune deficiency;
- History or any evidence of interstitial lung disease;
- History of human immunodeficiency virus (HIV);
- Active hepatitis B or active hepatitis C;
- Severe infections within 4 weeks prior to enrollment;
- Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0;
- History or current evidence of any condition, therapy or laboratory abnormality that might confound the results of the trial; interfere with the participant's participation for the full duration of the trial, or is negatively impacted by EP treatment, or is not in the best interest of the participant to participate in the opinion of the treating investigator;
- Prior allogeneic stem cell or solid organ transplant;
- Uncontrolled tumor-related pain; pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; or, hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Karmanos Cancer Institute
Detroit, Michigan, 48201
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, 22031
Greenville Memorial Hospital
Greenville, South Carolina, 29615
New York University Langone Medical Center - Perlmutter Cancer Center
New York, New York, 10016
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, 33612
About this study
Official title: An Open-Label, Multi-Center Trial of INO-5401 + INO-9012 in Combination With Atezolizumab in Subjects With Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
This was a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population was divided into two cohorts: Cohort A: participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-programmed death receptor-1/programmed death receptor ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: participants with locally advanced unresectable or metastatic/recurrent UCa, who were treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in was performed using a modified rolling six design, enrolling up to 6 participants (safety analysis participants) from Cohort A.
- Conditions
- Urothelial Carcinoma
- Being tested
- INO-5401, INO-9012, Atezolizumab, CELLECTRA® 2000
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-5401Biological
INO-5401: A mixture of 3 synthetic plasmids that target Wilms' tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) antigen.
IM injection
INO-9012Biological
INO-9012: A synthetic plasmid that expresses human interleukin-12 (IL-12).
IM injection.
AtezolizumabDrug
IV-Infusion.
CELLECTRA® 2000Device
IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Prior Anti-PD-1/PD-L1 | Experimental | Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti- programmed death receptor-1/ programmed cell death-ligand 1 (PD-1/PD-L1) therapy received INO-5401 9 milligrams (mg) and INO-9012 1 mg, intramuscular (IM) injection, followed by electroporation (EP) by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, intravenous (IV) infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator. Receives: Biological: INO-5401; Biological: INO-9012; Drug: Atezolizumab; Device: CELLECTRA® 2000 |
| Cohort B: Naïve Anti-PD-1/PD-L1 | Experimental | Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator. Receives: Biological: INO-5401; Biological: INO-9012; Drug: Atezolizumab; Device: CELLECTRA® 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs that occurred on or after Day 0. AESIs were toxicities and immune-mediated AEs that may have occurred up to 90 days after the last dose of trial treatment. AESIs were reported by the investigator to the Sponsor within 24 hours after learning of the event.
Measured: Up to approximately 71 months
Number of Participants With Clinically Significant Changes in Hematological Parameters
Clinically significant changes in hematological parameters were determined based on the investigator's discretion.
Measured: Up to approximately 71 months
Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters
Clinically significant changes in serum chemistry parameters were determined based on the investigator's discretion.
Measured: Up to approximately 71 months
Number of Participants With Clinically Significant Changes in Urinalysis Parameters
Clinically significant changes in urinalysis parameters were determined based on the investigator's discretion.
Measured: At baseline, Weeks 3, 6, 9, then every 6 weeks thereafter, up to 71 months
Antigen-Specific Immune Response
Blood and tissue samples were collected to evaluate the antigen-specific immune response to INO-5401 + INO-9012 in combination with atezolizumab. Planned assessments included: Enzyme Linked Immunosorbent Spot-forming (ELISpot) Assay, Flow cytometry, T cell receptor (TCR) sequencing, ELISA and/or gene expression analysis.
Measured: Up to approximately 71 months
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Review in Cohort A
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or a partial response (PR). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters) per RECIST 1.1.
Measured: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months
Secondary outcomes (6)
ORR as Assessed by RECIST Version 1.1 by Investigator Review in Cohort B
ORR was defined as the percentage of participants who had a confirmed CR or a PR. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters) per RECIST 1.1.
Measured: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months
Percentage of Participants With ORR by Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
ORR was defined as the percentage of participants who had a confirmed CR or a PR. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters) per iRECIST.
Measured: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months
Duration of Response (DoR)
DOR was defined as the time from the date of the first PR or CR to the date of death from any cause or date that progressive disease (PD) was objectively documented, whichever occurred first. CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial (nadir), including baseline. The sum also had to demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: From first documented confirmed CR or PR until first documentation of PD or death, whichever occurred first (approximately 71 months)
Progression-Free Survival (PFS) Per RECIST Version 1.1
PFS was defined as the time from the date of the start of investigational product treatment until the date of death from any cause or date that progression (+1 day) was objectively documented, whichever occurred first as assessed by RECIST Version 1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial (nadir), including baseline. The sum also had to demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: From the first dose of study drug to date of PD or death, whichever occurred first (up to approximately 71 months)
PFS Per Immune RECIST (iRECIST)
PFS was defined as the time from the date of the start of investigational product treatment until the date of death from any cause or date that progression (+1 day) was objectively documented, whichever occurred first as assessed by iRECIST Version 1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial (nadir), including baseline. The sum also had to demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: From Baseline to disease progression or death, whichever occurs first (up to approximately 71 months)
Overall Survival (OS)
OS was defined as the time from the date of the start of investigational product treatment until the date of death from any cause.
Measured: From date of first dose of study drug up to death from any cause, (approximately 71 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start24 Jul 2018
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Skolnik, MD, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502785
- Sponsor's protocol ID
- UCa-001
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2018
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Trial of INO-5401 + INO-9012 in Combination With Atezolizumab in Subjects With Locally Advanced Unresectable or Metastatic/Recurrent Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03502785
- Acronym / sponsor ID
- UCa-001
- Conditions
- Urothelial Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 2 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase I/IIA, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of INO-5401 + INO-9012 delivered by intramuscular (IM) injection followed by electroporation (EP), in combination with atezolizumab in participants with locally advanced unresectable or metastatic/recurrent Urothelial Carcinoma (UCa). The trial population was divided into two cohorts: Cohort A: participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti-programmed death receptor-1/programmed death receptor ligand-1 (anti-PD-1/PD-L1) therapy; Cohort B: participants with locally advanced unresectable or metastatic/recurrent UCa, who were treatment naïve and ineligible for cisplatin-based chemotherapy. A safety run-in was performed using a modified rolling six design, enrolling up to 6 participants (safety analysis participants) from Cohort A.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Prior Anti-PD-1/PD-L1 | Experimental | Biological: INO-5401, Biological: INO-9012, Drug: Atezolizumab, Device: CELLECTRA® 2000Participants with locally advanced unresectable or metastatic/recurrent UCa, who had confirmed disease progression during or following treatment with anti- programmed death receptor-1/ programmed cell death-ligand 1 (PD-1/PD-L1) therapy received INO-5401 9 milligrams (mg) and INO-9012 1 mg, intramuscular (IM) injection, followed by electroporation (EP) by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, intravenous (IV) infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator. |
| Cohort B: Naïve Anti-PD-1/PD-L1 | Experimental | Biological: INO-5401, Biological: INO-9012, Drug: Atezolizumab, Device: CELLECTRA® 2000Participants with locally advanced unresectable or metastatic/recurrent UCa who are treatment naïve and ineligible for cisplatin-based chemotherapy received INO-5401 9 mg and INO-9012 1 mg, IM injection, followed by EP by CELLECTRA® 2000 device, every 3 weeks until Week 9, then every 6 weeks for 6 more doses (until Week 45), thereafter every 12 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator in combination with atezolizumab 1200 mg, IV infusion, every 3 weeks, until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign an Informed Consent Form (ICF);
- Have histologically or cytologically documented locally advanced unresectable or metastatic/recurrent urothelial carcinoma (including renal pelvis, ureters, urinary bladder, and urethra);
- For Cohort A: Participants who have radiographically confirmed disease progression during or following treatment with an anti-PD-1/PD-L1 based therapy;
- For Cohort B: No prior chemotherapy for inoperable locally advanced or metastatic or recurrent UCa and ineligible ("unfit") for cisplatin-based chemotherapy;
- Have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
Key exclusion criteria (17 listed)
- Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0 as well as current participation or recipient of treatment on a clinical trial within 28 days prior to Day 0;
- Documented active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Malignancies other than UCa within 3 years prior to Day 0, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome;
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies;
- Treatment with systemic immunostimulatory agents;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INO-5401INO-5401: A mixture of 3 synthetic plasmids that target Wilms' tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) antigen. IM injection | Biological | Cohort A: Prior Anti-PD-1/PD-L1, Cohort B: Naïve Anti-PD-1/PD-L1 |
| INO-9012INO-9012: A synthetic plasmid that expresses human interleukin-12 (IL-12). IM injection. | Biological | Cohort A: Prior Anti-PD-1/PD-L1, Cohort B: Naïve Anti-PD-1/PD-L1 |
| AtezolizumabIV-Infusion. | Drug | Cohort A: Prior Anti-PD-1/PD-L1, Cohort B: Naïve Anti-PD-1/PD-L1 |
| CELLECTRA® 2000IM injection. | Device | Cohort A: Prior Anti-PD-1/PD-L1, Cohort B: Naïve Anti-PD-1/PD-L1 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment
Time frame: Up to approximately 71 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as any AEs that occurred on or after Day 0. AESIs were toxicities and immune-mediated AEs that may have occurred up to 90 days after the last dose of trial treatment. AESIs were reported by the investigator to the Sponsor within 24 hours after learning of the event.
Number of Participants With Clinically Significant Changes in Hematological Parameters
Time frame: Up to approximately 71 months
Clinically significant changes in hematological parameters were determined based on the investigator's discretion.
Number of Participants With Clinically Significant Changes in Serum Chemistry Parameters
Time frame: Up to approximately 71 months
Clinically significant changes in serum chemistry parameters were determined based on the investigator's discretion.
Number of Participants With Clinically Significant Changes in Urinalysis Parameters
Time frame: At baseline, Weeks 3, 6, 9, then every 6 weeks thereafter, up to 71 months
Clinically significant changes in urinalysis parameters were determined based on the investigator's discretion.
Antigen-Specific Immune Response
Time frame: Up to approximately 71 months
Blood and tissue samples were collected to evaluate the antigen-specific immune response to INO-5401 + INO-9012 in combination with atezolizumab. Planned assessments included: Enzyme Linked Immunosorbent Spot-forming (ELISpot) Assay, Flow cytometry, T cell receptor (TCR) sequencing, ELISA and/or gene expression analysis.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Review in Cohort A
Time frame: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or a partial response (PR). CR was defined as disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters) per RECIST 1.1.
6 secondary outcomes
ORR as Assessed by RECIST Version 1.1 by Investigator Review in Cohort B
Time frame: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months
Percentage of Participants With ORR by Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: From date of treatment start until date of first PD or death (whichever occurred first), up to approximately 71 months
Duration of Response (DoR)
Time frame: From first documented confirmed CR or PR until first documentation of PD or death, whichever occurred first (approximately 71 months)
Progression-Free Survival (PFS) Per RECIST Version 1.1
Time frame: From the first dose of study drug to date of PD or death, whichever occurred first (up to approximately 71 months)
PFS Per Immune RECIST (iRECIST)
Time frame: From Baseline to disease progression or death, whichever occurs first (up to approximately 71 months)
Overall Survival (OS)
Time frame: From date of first dose of study drug up to death from any cause, (approximately 71 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Skolnik, MD study director
Inovio Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INO-5401, INO-9012 and Atezolizumab in people with Urothelial Carcinoma, run by Inovio Pharmaceuticals at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Treatment (time frame: Up to approximately 71 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.